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GMP Quality Assurance Auditor I
Charles River Laboratories International Inc (CRL)
Wilmington, MA, US, 01887
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Basic Summary
We are seeking a Quality Assurance Auditor 1 for our Quality Assurance Department located in Wilmington, MA.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- The Quality Assurance Auditor 1 is responsible for performing audits of basic records, reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.
- Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor.
- Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
- Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures.
- Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
- Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained. May participate in the hosting of client site visits and support regulatory inspections.
- Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings. Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
MINIMUM QUALIFICATIONS:
- Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
- Minimum 1 year auditing experience in a GMP QA role.
- Knowledge of Microsoft Office applications.
- Must be able to comprehend regulations, documents and apply critical thinking skills.
- Must be detail oriented, communicate effectively verbally and in writing.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
About Biologics Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 18,000 employees within 100 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of >80% of the drugs approved by the FDA for the past 3 years.
Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
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Job posted: 2023-02-11
